FDA Law Blog: Biosimilars

JANUARY 15, 2024

By David B. Clissold & Sara W. Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. To quote the Fifth Circuit: “It was the regulatory equivalent of Romeo sending Mercutio on a wild goose chase—and then admitting there never was a goose while denying he even suggested the chase.

Documentation 113

Documentation 113

Pharmaceutical Commerce

JANUARY 15, 2024

FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.

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European Pharmaceutical Review

JANUARY 15, 2024

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Agamree ® (vamorolone), as a safer alternative to corticosteroids, for Duchenne muscular dystrophy (DMD). “In addition to its anti-inflammatory efficacy, both the EMA and the MHRA recognise the benefits of treatment with Agamree for bone health and growth,” Dr Shabir Hasham, Chief Medical Officer of Santhera Pharmaceuticals shared.

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pharmaphorum

JANUARY 15, 2024

Researchers at the University of Cambridge and Pfizer have developed an AI-powered approach to make it easier to design and make pharma molecules

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Compounding 119

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Communication

The Pharmacist

JANUARY 15, 2024

First-time buyers made up 45% of pharmacy sales brokered by business property advisor Christie & Co in the last year, it has revealed in its latest annual report. And 55% of pharmacies were sold to independent contractors and regional multiple operators, Christie & Co said. The rise in first-time buyers is almost double the number […] The post Nearly half of pharmacies sold to first-time buyers, reveals broker appeared first on The Pharmacist.

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European Pharmaceutical Review

JANUARY 15, 2024

The natural polymer tara gum polysaccharide ( Caesalpinia spinosa ) has application potential in pharmaceutical drug delivery , according to researchers in Korea. This is mainly due to its benefits such as its biocompatibility, biodegradability, and safety. A biodegradable alternative A study by the researchers, published in Carbohydrate Polymers , suggested that the material could be a natural, environmentally-friendly alternative to petroleum-based polymers such as plastic.

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pharmaphorum

JANUARY 15, 2024

Speculation about a takeover play for Cytokinetics isn’t going away, with Amgen the latest company to be linked to the company and its highly-anticipated cardiovascular drug aficamten.

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Outsourcing Pharma

JANUARY 15, 2024

Access to opioids such as fentanyl can lead to abuse but now two companies have signed an agreement to reduce the abuse potential while making sure they are still accessible to those who need them.

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pharmaphorum

JANUARY 15, 2024

Santhera’s new treatment for Duchenne muscular dystrophy Agamree has been launched in its first market, Germany, following its EU approval last month.

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The Pharmacist

JANUARY 15, 2024

Pharmacies offering the new Hypertension Case-Finding Service need to focus on converting more patients to ambulatory blood pressure monitoring (ABPM), according to a recent webinar by Community Pharmacy England (CPE). The service, relaunched on 1 December 2023, now requires contractors to have an ABPM device as well as their clinic meter. The CPE webinar, which […] The post Pharmacies urged to boost ambulatory blood pressure monitoring appeared first on The Pharmacist.

Community Pharmacies 87

Community Pharmacies 87

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pharmaphorum

JANUARY 15, 2024

MSD’s Keytruda has been cleared by the FDA as the first PD-1 inhibitor for newly diagnosed cervical cancer patients with less severe disease

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Pharma Times

JANUARY 15, 2024

CellVoyant’s platform combines AI with live cell imaging

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pharmaphorum

JANUARY 15, 2024

Germany’s IG BCE trade union has pushed back against any break-up of Bayer, claiming it could put thousands of domestic jobs at risk

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Pharma Times

JANUARY 15, 2024

Companies collaborate to launch walk-in pain clinic

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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

pharmaphorum

JANUARY 15, 2024

True innovation in life sciences is only possible through a connected, pan-European approach Mike.

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World Pharma News

JANUARY 15, 2024

Researchers have developed a platform that combines automated experiments with AI to predict how chemicals will react with one another, which could accelerate the design process for new drugs. Predicting how molecules will react is vital for the discovery and manufacture of new pharmaceuticals, but historically this has been a trial-and-error process, and the reactions often fail.

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Outsourcing Pharma

JANUARY 15, 2024

Cormica Bradford, a division of Cormica says it is proud to announce a significant expansion of its laboratory capabilities.

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Pharmafile

JANUARY 15, 2024

Boan Biotech has announced that it has completed subject enrolment for its international multicentre comparative phase 3 clinical trial of the company’s Denosumab injections (BA6101 and BA1102). The study will take place in Europe, the US and Japan, with a meeting having recently been held in Germany to share results from a phase 1 pharmacokinetic […] The post Boan Biotech completes enrolment for phase 3 study of Denosumab appeared first on Pharmafile.

Biosimilars 64

Biosimilars 64

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Outsourcing Pharma

JANUARY 15, 2024

SGD Pharma has announced its goal to become the global market leader in primary pharmaceutical glass packaging.

Packaging 91

Packaging 91

Drug Patent Watch

JANUARY 15, 2024

This chart shows the pharmaceutical companies with the most injectable dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most injectable dosed drugs… The post Which pharmaceutical companies have the most injectable dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceutical Companies Pharmaceutical Companies Dosage 59

Outsourcing Pharma

JANUARY 15, 2024

Cormica Bradford, a division of Cormica says it is proud to announce a significant expansion of its laboratory capabilities.

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Drug Patent Watch

JANUARY 15, 2024

Annual Drug Patent Expirations for PROLENSA Prolensa is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from two suppliers. There are nine… The post New patent expiration for Bausch And drug PROLENSA appeared first on DrugPatentWatch - Make Better Decisions.

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

Outsourcing Pharma

JANUARY 15, 2024

Access to opioids such as fentanyl can lead to abuse but now two companies have signed an agreement to reduce the abuse potential while making sure they are still accessible to those who need them.

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Drug Patent Watch

JANUARY 15, 2024

Annual Drug Patent Expirations for IGALMI Igalmi is a drug marketed by Bioxcel and is included in one NDA. It is available from one supplier. There are six patents protecting… The post New patent for Bioxcel drug IGALMI appeared first on DrugPatentWatch - Make Better Decisions.

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pharmaphorum

JANUARY 15, 2024

Artificial intelligence (AI) is transforming the healthcare industry, particularly in decision-making and therapeutic advancements. Learn how AI will revolutionise healthcare and impact future decision-making processes in this informative article.

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Drug Patent Watch

JANUARY 15, 2024

Annual Drug Patent Expirations for LAZANDA Lazanda is a drug marketed by Btcp Pharma and is included in one NDA. There are five patents protecting this drug. This drug has… The post New patent expiration for Btcp Pharma drug LAZANDA appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmacy Management

pharmaphorum

JANUARY 15, 2024

Orion buys stake in LegoChem amid pivot to cancer and pain Phil.

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Drug Patent Watch

JANUARY 15, 2024

Annual Drug Patent Expirations for ORGOVYX Orgovyx is a drug marketed by Sumitomo Pharma and is included in one NDA. It is available from one supplier. There are eight patents… The post New patent for Sumitomo Pharma drug ORGOVYX appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceutical Commerce

JANUARY 15, 2024

The group—known as the Innovators' Network—is meant to serve as a link between entrepreneurs, providers, researchers, and payers while they strive to combat cardiovascular disease.

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Drug Patent Watch

JANUARY 15, 2024

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. It is available from one supplier. There are fifty-four… The post New patent for Amicus Therap drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.

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Proxsys Rx

JANUARY 15, 2024

In late 2022, ProxsysRx’s team initiated 340B Program-Management support for a 198-bed, full-service, community and regional non-profit medical center located in the Northeast. After weeks of laying all the necessary groundwork to manage its 340B program, we began actively submitting eligible prescriptions this past January. By the end of Q1, the hospital’s 2023 340B savings & revenue had surpassed its total for all of 2022.

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Mail-Order Pharmacies Specialty Pharmacies Hospitals Communication 52